Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-04 @ 9:20 AM
Study NCT ID:
NCT02822235
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2016-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-interventional Study of Moderate to Severe Inflammatory Bowel Disease in Brazil
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
Real-world Data of Moderate to Severe Inflammatory Bowel Disease in Brazil: a Non-interventional, Multicenter Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life (RISE BR)
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to gather information regarding the population with moderate to severe inflammatory bowel disease (IBD), the burden of the disease, and understand their treatment patterns, particularly on the use of available biologic therapies.
Detailed Description:
This is a non-interventional study to determine the rate of control of disease activity in moderate to severe inflammatory bowel disease (IBD) participants, with two parts: cross-sectional evaluation (Day 1) with retrospective data collection and a prospective 12-month evaluation for patients with active IBD at cross-sectional evaluation (Day 1).
The study enrolled 407 patients. This multicenter trial was conducted in Brazil. Retrospective data of previous IBD treatments (drug, dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years will be collected. Prospective data was collected for a period of 12 months in participants with active disease. UC participants, with no or light disease activity at Day 1 did not continue to 12-month follow up. CD participants, with no or light disease activity at Day 1 but with colonoscopy or calprotectin levels (i.e, calprotectin \>200 ug/g) in the previous year suggestive of inadequate control of activity progressed to 12-month follow up.
The study enrolled 407 patients. This multicenter trial was conducted in Brazil. Retrospective data of previous IBD treatments (drug, dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years will be collected. Prospective data was collected for a period of 12 months in participants with active disease. UC participants, with no or light disease activity at Day 1 did not continue to 12-month follow up. CD participants, with no or light disease activity at Day 1 but with colonoscopy or calprotectin levels (i.e, calprotectin \>200 ug/g) in the previous year suggestive of inadequate control of activity progressed to 12-month follow up.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1178-66445 | REGISTRY | WHO | View |